18F-PSMA PET/CT for visualization of glioblastoma multiforme

18F-PSMA PET/CT for visualization of glioblastoma multiforme - PSMA-GBM

Status

Recruiting

Phases

Phase 2

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON48577

Enrollment

Registered

2018-11-07

Start date

2019-02-28

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

glioblastoma multiforme high grade glioma

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Suspected GBM on MRI scan, - Scheduled for tumor resection at Radboudumc, - Age *18 years

Exclusion criteria

Exclusion criteria: - Age < 18 years, - Pregnancy or the wish to become pregnant within 6 months, - Creatinine clearance below 40ml/min, - Liver disease defined as aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range

Design outcomes

Primary

Measure	Time frame
* The uptake of 18F-PSMA PET/CT in suspected GBM lesions These data will be presented in a quantitative way. Activity is determined in a volume of interest (VOI) based on a relative threshold (>70% of the maximum voxel value within the VOI : VOI70%). Maximum standardized uptake in this VOI (SUVmax) and target to background ratios (TBR) are determined.	—

Secondary

Measure	Time frame
* The correlation between PSMA protein and RNA expression with 18F-PSMA PET/CT uptake. PSMA protein and RNA expression will be presented in a quantitative way (FPKM as determined in targeted RNAsequencing analysis), and it will be plotted against 18F-PSMA uptake (SUVmax). Correlation will be described with the Pearsons correlation coefficient. * Correlation between 18F-PSMA PET/CT and T1GdMRI Qualified radiologist and nuclear medicine physician will review the images and compare them qualitatively (tumor delineation etc).	—

Measure

Time frame

* The correlation between PSMA protein and RNA expression with 18F-PSMA PET/CT uptake. PSMA protein and RNA expression will be presented in a quantitative way (FPKM as determined in targeted RNAsequencing analysis), and it will be plotted against 18F-PSMA uptake (SUVmax). Correlation will be described with the Pearsons correlation coefficient. * Correlation between 18F-PSMA PET/CT and T1GdMRI Qualified radiologist and nuclear medicine physician will review the images and compare them qualitatively (tumor delineation etc).

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Countries

Netherlands

Outcome results